Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.

Not Applicable

Completed

• Conditions: Interstitial Lung Disease
• Interventions: Procedure: transbronchial lung biopsy

• Registration Number: NCT01894113
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease

Detailed Description

Endoscopic biopsy currently plays only a minor role for the diagnosis of interstitial lung disease. However, in some cases obtaining lung tissue is necessary to establish a final diagnosis. The current standard procedure is transbronchial forceps biopsy - if not sufficient: surgical lung biopsy. Transbronchial lung biopsy bears essential limitations however:

* Small tissue sample

* Limited evaluability of the material caused by forceps-induced crush artifacts

In cryobiopsy the cryoprobe´s tip is being cooled and thereby cools the surrounding tissue to approximately minus 89 degrees Celsius. Subsequently, the frozen probe is retracted with the frozen tissue being attached onto the frozen probe's tip. When applied in the central airways, cryobiopsy proved to deliver large specimens of good quality, which may exceed forceps biopsies in terms of diagnostic yield. Pilot studies on transbronchial cryobiopsy showed that same advantages as seen in the endobronchial use.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-02
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

1. Clinical indications for biopsy of interstitial lung disease
2. Age over 18 years
3. Signed consent

Exclusion Criteria

1. Risk of bleeding / ongoing anticoagulation
2. Oxygen saturation <90% - despite delivery of 2l oxygen / min
3. Underlying cardiac disease (unstable angina, myocardial infarction during the last month, congestive heart failure)
4. Pulmonary hypertension, PAP sys> 50mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transbronchail cryo lung biopsy	transbronchial lung biopsy	transbronchial lungbiopsy with cryoprobe
transbronchial forceps lung biopsy	transbronchial lung biopsy	transbronchial lung biopsy forceps

Primary Outcome Measures

Name	Time	Method
Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.	24 months

Secondary Outcome Measures

Name	Time	Method
Differences in the final diagnosis	24 Months

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany